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510(k) K020347

AGC SPEZIALLEGIERUNG by Wieland Edelmetalle GmbH & Co. — Product Code EJT

K020347 is an FDA 510(k) premarket notification submitted by Wieland Edelmetalle GmbH & Co. for the device "AGC SPEZIALLEGIERUNG". The FDA issued a decision of Substantially Equivalent on April 24, 2002. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Wieland Edelmetalle GmbH & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2002
Date Received
February 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Wieland Edelmetalle GmbH & Co.

  • K012839 — AUROPAL, ORDER-NO.: 2101 (December 31, 2001)
  • K012841 — DUO PAL 6, ORDER-NO.: 2154 (November 20, 2001)
  • K012843 — PORTADUR P 2, MODEL #2031 (November 2, 2001)
  • K012831 — BIO PORTADUR, ORDER-NO.:2017 (November 1, 2001)
  • K012828 — PORTA SMK 82, MODEL 2032 (November 1, 2001)
  • K012834 — PORTA GEO TI MODEL #2004 (November 1, 2001)
  • K012827 — PORTA AURIUM, MODEL 2067 (November 1, 2001)
  • K012835 — PORTA MAXIMUM, MODEL# 2066 (November 1, 2001)
  • K012826 — BIOPORTA G, MODEL 2052 (November 1, 2001)
  • K012840 — EURO 45, ORDER-NO.: 2064 (October 23, 2001)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources